Health Care > EXAM > CITI Training Test Prep | 134 Questions with 100% Correct Answers (All)

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CITI Training Test Prep | 134 Questions with 100% Correct Answers

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What must you file before conducting human clinical trials with an experimental drug? - ✔✔IND application (Form FDA 1571) During the clinical development phase of the IND process, what must spon ... sors do? - ✔✔Maintain current IND application by amending IND with new Form FDA 1571 and providing FDA with: safety updates copies of new protocols FDA 1572 Annual Progress reports this document notifies FDA of relevant changes in investigators conducting clinical trials under the IND. - ✔✔Form FDA 1572 What is the timeline of drug development? - ✔✔Preclinical trials, IND Submission, Clinical Development (Phase I-III), NDA submission, Marketing (Phase IV) When does a sponsor submit the IND? - ✔✔Prior to clinical development phases (human trials). *30 day process. What is the NDA? - ✔✔New Drug Application, submitted prior to Phase IV marketing phase. How long does the NDA submission take? - ✔✔6 months - 2 years. What is determined for a drug in the preclinical phase - ✔✔Pharmacokinetics and bioavailability Outcome shows promise of safety and efficacy warranting additional studying. How long does FDA have to review IND submission? - ✔✔30 days How long is the clinical development phase (Phase 1-III) in process for IND? - ✔✔6-7 years. [Show More]

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